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FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System

Legacy MEDSearch

Data pooled from both the US and European/UK trials were used to assess the clinical safety and efficacy of histotripsy in destroying targeted primary and secondary liver tumors. was achieved indicating that physicians can precisely target and destroy liver tissue and unresectable liver tumors.

FDA 52
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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

Covered SoHO activities are “action[s], or series of actions, that [have] a direct impact on safety, quality or efficacy of SoHOs.” This will enable better monitoring of the safety and quality of these products, but it may also require additional investments in IT infrastructure.

Safety 75
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Japan’s M&A Boom

Pharmaceutical Technology

“In 2001, Japan’s Taisho Pharmaceutical tried to merge with Tanabe, but it failed due to differences in corporate culture.’ ” Even though the government is supporting use of generic drugs in Japan, there is still distrust from physicians as in the past generic drug companies have been small and often sub-standard.